For professional in-vitro diagnostic use only
Second Generation (II) of NZYTech SARS-CoV-2 kits – Different targets in Different channels
Triple target assay (SARS-CoV-2, RdRp and N genes, and human RP gene)
Positive control to validate assay included
Internal control to confirm extraction / inhibition included
High Sensitivity: Early virus detection and diagnosis, detects as low as 250 copies of viral RNA /mL (LoD) sample (equivalent to 5 copies per reaction)
Precision: Coefficient of variation (CV) < 3%, allowing reproducible test results
High Throughput: Up to 94 clinical samples (96-well plate); up to 382 clinical samples (384-well plate)
High Specificity: Proven by in silico analysis as well as wet lab testing
Flexibility: Assay validated on widely used qPCR instruments including ABI® 7500 FAST, ABI® QuantStudio™ 5, ABI® QuantStudio™ 6 Pro, Bio-Rad® CFX96
Fast Time: < 40 min from nucleic acid extraction to results (for some validated qPCR instruments).
Minimal Sample Input: As low as 2 μL sample needed
Description:
NZYTech SARS-CoV-2 One-Step RT-PCR Kit II, RdRp and N genes (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common real-time PCR platforms. The virus RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes have previously been identified as highly specific markers for SARS-CoV-2. This NZYTech kit targets specific regions in the RdRp and N genes of SARS-CoV-2 genome to provide the highest sensitivity of detection. By using NZYTech SARS-CoV-2 One-Step RT-PCR Kit II, RdRp and N genes (IVD), RNA isolated and purified with a CE IVD extration system is retrotranscribed (RT) to cDNA and subsequently amplified by PCR, in a single reaction, using three highly specific primer/probe sets exploiting the so-called TaqMan® principle. During this process, the probes specifically anneal to two regions of the SARS-CoV-2 genome, namely RdRp (within the Orf1ab polyprotein gene) and N genes, in case the sample was extracted from an infected patient. An additional primers/probe set acts as an endogenous internal control to detect nucleic acids of the human ribonuclease P [RNase P gene (RP)], assessing sample quality. In addition, this internal control demonstrates that no reaction inhibition has occurred by PCR inhibitors potentially present in the clinical/environmental samples. To allow identifying the amplification of the three specific targets in a single reaction, SARS-CoV-2 (RdRp and N genes) and human RNase P specific probes are differently labelled, with HEX™, FAM™ and Cy5™ reporter dyes, respectively. Note that this panel contains a duplex assay in two distinct optical channels – HEX™ and FAM™ – to report performance of the two PCR assays for SARS-CoV-2 detection. In addition, they are provided in optimized concentrations to make sure amplification of human mRNA, even when present at very high concentrations, does not limit the efficiency of the SARS-CoV-2 primers/probe sets.
Components:
– NZYSupreme One-step RT-qPCR Master Mix, ROX
– SARS-CoV-2/RP primers/probe Mix II (HEX™, FAM™ and Cy5™ labelled)
– SARS-CoV-2 (RdRp & N genes)/RP Positive Control (1 x 104 copies/μL)
– No-Template Control
Storage conditions: -30°C to -15°C
Shipping conditions: Shipped with dry ice
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